A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

ID#: NCT03524092

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: October 19, 2018

End Date: March 22, 2022

Contact Information:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
Summary: The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
Eligibility:

Inclusion Criteria:

- Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.

- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.

- If female, must meet the contraception requirements.

Exclusion Criteria:

- Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).

- Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.

- Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).

- Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).

- Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).

- Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
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